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Patent 3033276 Summary

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Claims and Abstract availability

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  • At the time the application is open to public inspection;
  • At the time of issue of the patent (grant).
(12) Patent: (11) CA 3033276
(54) English Title: CATHETER INSERTION DEVICE
(54) French Title: DISPOSITIF D'INSERTION DE CATHETER
Status: Granted
Bibliographic Data
(51) International Patent Classification (IPC):
  • A61M 25/01 (2006.01)
  • A61M 25/06 (2006.01)
  • A61M 25/09 (2006.01)
(72) Inventors :
  • KORKUCH, CHRIS (United States of America)
  • KUEHN, JEFFREY P. (United States of America)
  • PIEPRZYK, DREW (United States of America)
(73) Owners :
  • TELEFLEX MEDICAL INCORPORATED (United States of America)
(71) Applicants :
  • TELEFLEX MEDICAL INCORPORATED (United States of America)
(74) Agent: ROBIC AGENCE PI S.E.C./ROBIC IP AGENCY LP
(74) Associate agent:
(45) Issued: 2021-04-20
(22) Filed Date: 2014-06-17
(41) Open to Public Inspection: 2015-02-19
Examination requested: 2019-02-07
Availability of licence: N/A
(25) Language of filing: English

Patent Cooperation Treaty (PCT): No

(30) Application Priority Data:
Application No. Country/Territory Date
61/865.944 United States of America 2013-08-14
14/205.307 United States of America 2014-03-11

Abstracts

English Abstract

A catheter insertion device that allows for single-handed insertion of the catheter within the vasculature of the patient is disclosed. The catheter insertion device includes a handle, a needle cannula partially within the handle, a guidewire partially within the handle and the needle cannula, and a first actuator connected to the handle and the guidewire. The first actuator is movable in a proximal direction relative to the handle to cause the guidewire to move in a distal direction away from the handle, and is movable in a distal direction relative to the handle to cause the guidewire to move in a proximal direction towards the handle. The catheter insertion device can also include a needle support that stabilizes the needle cannula during insertion of the needle cannula into a patient.


French Abstract

Un dispositif dinsertion de cathéter qui permet linsertion à une seule main du cathéter dans le système vasculaire du patient est décrit. Le dispositif dinsertion de cathéter comprend une poignée, une canule daiguille partiellement dans la poignée, un fil-guide partiellement dans la poignée et la canule daiguille et un premier actionneur raccordé à la poignée et au fil-guide. Le premier actionneur est mobile dans une direction proximale par rapport à la poignée pour amener le fil-guide à se déplacer dans une direction distale en séloignant de la poignée et est mobile dans une direction distale par rapport à la poignée pour amener le fil-guide à se déplacer dans une direction proximale vers la poignée. Le dispositif dinsertion de cathéter peut comprendre également un support daiguille qui stabilise la canule daiguille pendant linsertion de la canule daiguille dans un patient.

Claims

Note: Claims are shown in the official language in which they were submitted.


Claims
1. A catheter insertion device, comprising:
an insertion group comprising a handle, a needle cannula partially within the
handle, and
a needle support connected to the handle;
a first actuator having a bottom surface; and
a catheter group comprising an elongated catheter with a proximal end and a
catheter hub
connected to the proximal end of the elongated catheter, wherein:
the needle support comprises two parallel features separated by a distance
greater than an
outer diameter of the elongated catheter to stabilize the needle cannula
during insertion of the
needle cannula into a patient, wherein the needle support further comprises a
top portion
configured to abut the bottom surface of the first actuator to prevent
movement of the needle
support relative to the handle, and
the needle cannula having a cantilever portion extending from the handle, the
needle
support being configured to support the needle cannula on the cantilever
portion.
2. The catheter insertion device of claim 1, wherein the needle support is
configured
to move relative to the handle upon abutment of the catheter hub to the needle
support.
3. The catheter insertion device of claim 1 or 2, wherein the needle
support is
configured to move relative to the handle by swinging upward or downward
relative to the
handle.
4. The catheter insertion device of any one of claims 1 to 3, wherein the
two parallel
features are two parallel walls.
Date Recue/Date Received 2020-07-13

5. The catheter insertion device of any one of claims 1 to 4, wherein the
handle
comprises a top arm having a distal region, and the needle support is
connected to the distal
region of the top arm of the handle.
6. The catheter insertion device of any one claims 1 to 5, wherein the
needle support
is configured to stabilize an intermediate portion of the needle cannula
during insertion of the
needle cannula into a patient, said intermediate portion of the needle cannula
freely extending
from the handle.
7. The catheter insertion device of any one of claims 1 to 6, further
comprising a
guidewire partially within the handle and the needle cannula.
8. The catheter insertion device of claim 7, wherein the first actuator is
connected to
the handle and the guidewire, the first actuator being movable relative to the
handle to move the
guidewire relative to the handle.
9. The catheter insertion device of claim 8, wherein the guidewire has a
proximal
end and the first actuator comprises an arm extending downward from the bottom
surface of the
first actuator, the arm being connected to the proximal end of the guidewire.
10. The catheter insertion device of claim 8 or 9, wherein the first
actuator is a slider
operable to slide over a portion of the handle.
11. The catheter insertion device of any one of claims 8 to 10, further
comprising a
second actuator connected to the handle, the second actuator being movable
relative to the
handle to push the catheter group relative to the handle.
31
Date Recue/Date Received 2020-07-13

12. The catheter insertion device of claim 11, wherein the second actuator
comprises
a notch configured to receive a portion of the catheter hub.
13. The catheter insertion device of claim 11 or 12, wherein the second
actuator
comprises an enlarged proximal end that engages with the handle to limit
travel of the second
actuator relative to the handle.
14. A catheter insertion device comprising:
a handle having a distal region including a top arm and a bottom arm;
a needle cannula anchored within the handle and disposed partially between the
top
arm and the bottom arm, the needle cannula comprising a sharp distal tip
extending distally
from the handle;
a catheter group removably connected to the handle, the catheter group
comprising an
elongated catheter with a proximal end and a catheter hub connected to the
proximal end of
the elongated catheter, the catheter group configured to slide relative to the
handle and the
needle cannula; and
a needle support pivotably connected to the handle and configured to stabilize
a
portion of the needle cannula extending from the handle during insertion of
the needle
cannula into a patient, the needle support further configured to swing
relative to the handle
during removal of the catheter group from the handle.
15. The catheter insertion device of claim 14, further comprising a first
actuator
movable between a first position and a second position, wherein the needle
support is
configured to block advancement of the catheter group when the first actuator
is in the first
32
Date Recue/Date Received 2020-07-13

position and permit advancement of the catheter group when the first actuator
is in the
second position.
16. The catheter insertion device of claim 14, the needle cannula having a
tip, the
device further comprising a guidewire and a first actuator for extending or
retracting the
guidewire, wherein the needle support is prevented from pivoting relative to
the handle
before the first actuator is moved to extend the guidewire distally past the
tip of the needle
cannula.
17. The catheter insertion device of claim 14, wherein the needle support
comprises
two parallel walls separated by a distance greater than an outer diameter of
the elongated
catheter.
18. The catheter insertion device of claim 17, wherein the two parallel
walls are
perpendicular to a top surface of the bottom arm.
19. The catheter insertion device of any one of claims 14, 17 and 18,
further
comprising a guidewire partially disposed within the handle and the needle
cannula.
20. The catheter insertion device of claim 19, wherein the handle comprises
a
looped proximal end portion that defines a channel that holds a portion of the
guidewire.
21. The catheter insertion device of claim 19 or 20, further comprising a
first
actuator connected to the handle and the guidewire, the first actuator
configured to move the
guidewire relative to the handle.
33
Date Recue/Date Received 2020-07-13

22. The catheter insertion device of claim 21, wherein the guidewire has a
proximal
end and the first actuator is a slider configured to move by sliding over a
portion of the
handle, the first actuator comprising an arm connected to the proximal end of
the guidewire
and extending downward from a bottom surface of the first actuator.
23. The catheter insertion device of claim 22, wherein the arm comprises a
through-
hole and the proximal end of the guidewire is secured within the through-hole.
24. The catheter insertion device of claim 23, wherein the proximal end of
the
guidewire comprises a ball having a diameter greater than a diameter of the
through-hole,
such that the guidewire is secured within the through-hole by an interference
fit.
25. The catheter insertion device of any one of claims 21 to 24, wherein
the first
actuator has a bottom surface and the needle support comprises a top portion
configured to
abut the bottom surface of the first actuator to prevent movement of the
needle support
relative to the handle.
26. The catheter insertion device of any one of claims 21 to 25, further
comprising a
second actuator connected to the handle, the second actuator being movable
relative to the
handle to push the catheter group relative to the handle.
27. The catheter insertion device of claim 26, wherein the second actuator
comprises a notch configured to receive a portion of the catheter hub.
28. The catheter insertion device of claim 26 or 27, wherein the second
actuator
comprises an enlarged proximal end that engages with the handle to limit
travel of the second
actuator relative to the handle.
34
Date Recue/Date Received 2020-07-13

29. The catheter insertion device of any one of claims 14 to 28, wherein
the top arm
of the handle has a distal region and the needle support is pivotably
connected to the distal
region of the top arm of the handle.
30. The catheter insertion device of any one of claims 14 to 29, wherein
the needle
support is configured to move relative to the handle upon abutment of the
catheter hub to the
needle support.
31. The catheter insertion device of any one of claims 14 to 30, wherein
the needle
support is configured to move relative to the handle by swinging upward or
downward
relative to the handle.
32. The catheter insertion device of any one of claims 14 to 31, wherein
the top arm
of the handle includes a groove configured to receive a corresponding tongue
of a needle
guard for stably securing the needle guard to the handle.
33. The catheter insertion device of any one of claims 14 to 32, further
comprising a
needle safety clip that covers the sharp distal tip of the needle cannula
following removal of
the needle cannula from the catheter hub.
Date Recue/Date Received 2020-07-13

Description

Note: Descriptions are shown in the official language in which they were submitted.


CATHETER INSERTION DEVICE
TECHNICAL FIELD
[0001] This disclosure generally relates to medical devices for use in
insertion of
catheters or other medical equipment into the vasculature of a patient. More
particularly, this
disclosure relates to a catheter insertion device for at least partial
insertion of a catheter within
the vasculature of the patient.
BACKGROUND
[0002] Different types of medical devices, such as needles, introducers,
trocars,
catheters, stents, angiography balloons, cutting tools, and imaging tools can
be introduced
into the body for various medical procedures. For example, catheters are used
to introduce or
remove fluids from vessels in the body for a variety of medical procedures. In
atypical
procedure, to insert a catheter in a vessel, the vessel access is first
verified by aspiration using
a long hollow needle, such as a syringe needle. A guidewire is then passed
through the needle
into the vessel. The guidewire acts as a track for the catheter to pass over
to reach a target
location within the vessel. A catheter is finally passed over the guidewire to
the target
location in the vasculature of the patient. With the catheter in place, the
needle and the
guidewire are removed, leaving only the catheter in the vessel. Fluids are
then introduced or
removed from the vessel through the catheter by connecting a fluid source or
aspiration
device to the catheter hub.
[0003] Various devices are known for placement of a catheter in the
vasculature of a
patient. The maintenance of sterility of the various components of the device
by, for
example, preventing the contact of the fingers of the operator with the
various parts of the
needle, the guidewire and the catheter itself during operation, is important
for use of these
devices. However, known catheter placement devices typically require the use
of two hands
1
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for the insertion of the guide wire and advancement of the catheter into the
vasculature, which
increases the risk of contamination, increases the risk of inadvertently
damaging the vessel
due to unintended needle point movement, prevents the continuous use of
ultrasound from the
point of skin penetration, vessel access, wire guide insertion, through to
having the first distal
portion of the catheter in the vessel and needle point shielded, and makes the
device less
convenient for use.
[0004] Therefore, a need exists for a novel catheter insertion device that
allows for
single-handed insertion of the catheter within the vasculature of the patient.
SUMMARY
[0005] The foregoing needs are met, to a great extent, by implementations of
the
catheter insertion device according to this disclosure.
[0006] In accordance with one implementation, a catheter insertion device
includes a
handle, a needle cannula partially within the handle, a guidewire partially
within the handle
and the needle cannula, and a first actuator connected to the handle and the
guidewire. The
needle cannula includes a sharp distal tip extending distally from the handle.
The first
actuator is movable relative to the handle to move the guidewire relative to
the handle, such
that moving the first actuator in a proximal direction relative to the handle
causes a distal end
of the guidewire to move in a distal direction away from the handle, and
moving the first
actuator in a distal direction relative to the handle causes the distal end of
the guidewire to
move in a proximal direction towards the handle.
[0007] In some implementations, the first actuator can be a slider which is
moved by
sliding over a portion of the handle, and the first actuator can include an
arm extending
downward from the bottom surface of the first actuator. The arm can be
connected to a
proximal end of the guidewire. The arm can include a through hole, where the
proximal end
2
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of the guidewire can be secured within the through hole. The proximal end of
the guidewire
can include a ball, where the diameter of the ball can be greater than the
diameter of the
through hole, such that the guidewire can secured within the through hole by
an interference
fit.
[0008] In some implementations, the handle can include a looped proximal end
portion that can define a channel that holds a portion of the guidewire. The
catheter insertion
device can also include a catheter assembly removably connected to the handle,
where the
catheter assembly can include an elongated catheter connected to a catheter
hub. The catheter
insertion device can also include a needle safety clip that can cover the
sharp distal tip of the
needle cannula following removal of the needle cannula from the catheter hub.
The catheter
hub can house a hemostasis valve. The hemostasis valve can include a distal
piece and a
proximal piece that when mated define a closed inner cavity. The volume of the
closed inner
cavity defined by the proximal piece can be greater than any volume of the
inner cavity
defined by the distal piece.
[0009] In some implementations, the catheter insertion device can also include
a
second actuator connected to the handle, where the second actuator can be
movable relative to
the handle to push the catheter group relative to the handle. The second
actuator can include
a notch to receive a portion of the catheter hub. The second actuator can
include an enlarged
proximal end that engages with the handle to limit travel of the second
actuator relative to the
handle.
[0010] In some implementations, the catheter insertion device can also include
a
needle support connected to the handle, where the needle support can stabilize
an
intermediate portion of the needle cannula during insertion of the needle
cannula into a
patient. The intermediate portion of the needle cannula can freely extend from
the handle.
3
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The needle support can include a top portion that abuts a bottom surface of
the first
actuator to prevent movement of the needle support relative to the handle.
[0011]
According to another implementation, a catheter insertion device includes an
insertion group including a handle, a needle cannula partially within the
handle, and a needle
support connected to the handle. The catheter insertion device also includes a
first actuator
having a bottom surface, and a catheter group comprising an elongated catheter
with a
proximal end and a catheter hub connected to the proximal end of the elongated
catheter. The
needle support includes two parallel features separated by a distance greater
than an outer
diameter of the elongated catheter to stabilize the needle cannula during
insertion of the
needle cannula into a patient. The needle support further comprises a top
portion configured
to abut the bottom surface of the first actuator to prevent movement of the
needle support
relative to the handle. The needle cannula has a cantilever portion extending
from the handle,
where the needle support supports the needle cannula on the cantilever
portion.
[0011a] According to another implementation, a catheter insertion device
comprises a
handle having a distal region including a top arm and a bottom arm; a needle
cannula
anchored within the handle and disposed partially between the top arm and the
bottom arm,
the needle cannula comprising a sharp distal tip extending distally from the
handle; a catheter
group removably connected to the handle, the catheter group comprising an
elongated catheter
with a proximal end and a catheter hub connected to the proximal end of the
elongated
catheter, the catheter group configured to slide relative to the handle and
the needle cannula;
and a needle support pivotably connected to the handle and configured to
stabilize a portion of
the needle cannula extending from the handle during insertion of the needle
cannula into a
patient, the needle support further configured to swing relative to the handle
during removal
of the catheter group from the handle.
4
Date Recue/Date Received 2020-07-13

[0012] In some implementations, the needle support can move relative
to the handle
upon abutment of the catheter hub to the needle support. The needle support
can move
relative to the handle by swinging upward or downward relative to the handle.
The two
parallel features can be two parallel walls. The handle can include a top arm,
and the needle
support can be connected to a distal region of the top arm of the handle.
[0013] According to another implementation, a catheter insertion
device includes a
handle having a distal region including a top arm and a bottom arm; a needle
cannula
anchored within the handle and disposed partially between the top arm and the
bottom arm.
The needle cannula comprises a sharp distal tip extending distally from the
handle. The
catheter insertion device further includes a catheter group removably
connected to the handle,
the catheter group comprising an elongated catheter and a catheter hub
connected to a
proximal end of the elongated catheter, the catheter group configured to slide
relative to the
handle and the needle cannula. The catheter insertion device further includes
a needle support
pivotably connected to the handle and configured to stabilize a portion of the
needle cannula
4a
Date Recue/Date Received 2020-07-13

extending from the handle during insertion of the needle cannula into a
patient, the needle
support further configured to swing upwards during removal of the catheter
group from the
handle.
[0014] According to another implementation, a method of using a catheter
insertion
device is disclosed. Initially, a practitioner receives the catheter insertion
device. The
catheter insertion device includes a handle, a needle cannula partially within
the handle, a
guidewire partially within the handle and the needle cannula, a first actuator
connected to the
handle and the guidewire, a catheter group removably connected to the handle,
and a second
actuator connected to the handle. The needle cannula includes a sharp distal
tip extending
distally from the handle. The first actuator is movable relative to the handle
to move the
guidewire relative to the handle. The catheter group includes an elongated
catheter and a
catheter hub connected to the proximal end of the elongated catheter. The
second actuator is
movable relative to the handle to move the catheter group relative to the
handle.
[0015] Next, the practitioner grips the handle using a hand of the
practitioner. The
practitioner then navigates the handle until the sharp distal tip of the
needle cannula is within
the vasculature of a patient. Next, the practitioner actuates the first
actuator using a first
finger to cause a distal tip of the guidewire to move in a distal direction
relative to the handle
and within the vasculature of the patient. Finally, the practitioner actuates
the second actuator
using the first finger of the practitioner to cause the catheter group to move
in a distal
direction relative to the handle so that the distal end of the elongated
catheter is inserted
within the vasculature of the patient.
[0016] In some implementations, the handle can include a first side and a
second side
opposite the first side. The practitioner can then grip the first side using a
second finger of
the hand of the practitioner and grip the second side using a third, different
finger of the hand
of the practitioner. The first actuator can be actuated in a proximal
direction using the first
CA 3033276 2019-02-07

finger of the hand of the practitioner to cause a distal tip of the guidewire
to move in a distal
direction relative to the handle and within the vasculature of the patient,
and the second
actuator can be actuated in a distal direction using the first finger of the
practitioner to cause
the catheter group to move in a distal direction relative to the handle so
that the distal end of
the elongated catheter is inserted within the vasculature of the patient.
[0017] In some implementations, the practitioner can grip the catheter hub
with his
other hand while pulling the handle in a proximal direction to separate the
catheter group
from the handle. The practitioner can grip the handle overhand, such that the
first finger can
be the index finger of the hand of the practitioner. The practitioner can grip
the handle
underhand, such that the first finger can be the index finger of the hand of
the practitioner.
[0018] According to another implementation, a method of inserting a catheter
is
disclosed. Initially, a catheter insertion device is received. The catheter
insertion device
includes a handle, a needle cannula partially within the handle, a guidewire
partially within
the handle and the needle cannula, a first actuator connected to the handle
and the guidewire,
a catheter group removably connected to the handle, and a second actuator
connected to the
handle. The needle cannula includes a sharp distal tip extending distally from
the handle.
The first actuator is movable relative to the handle to move the guidewire
relative to the
handle. The catheter group includes an elongated catheter and a catheter hub
connected to the
proximal end of the elongated catheter. The second actuator is movable
relative to the handle
to move the catheter group relative to the handle.
[0019] Next, the first actuator is actuated using a finger to cause a distal
tip of the
guidewire to move in a distal direction relative to the handle and within the
vasculature of the
patient. The second actuator is actuated using the same finger to cause the
catheter group to
move in a distal direction relative to the handle so that the distal end of
the elongated catheter
is inserted within the vasculature of the patient.
6
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[0020] Certain implementations of the catheter insertion device have been
outlined so
that the detailed description below may be better understood. There are, of
course, additional
implementations that will be described below.
[0021] In this respect, before explaining at least one implementation in
detail, it is to
be understood that the catheter insertion device is not limited in its
application to the details
of construction and to the arrangements of the components set forth in the
following
disclosure or illustrated in the drawings. Also, it is to be understood that
the phraseology and
terminology employed herein, as well as in the Abstract, are for the purpose
of description
and should not be regarded as limiting.
[0022] As such, those skilled in the art will appreciate that the conception
upon which
this disclosure is based may readily be utilized as a basis for the designing
of other structures,
methods, and systems for carrying out the several purposes of the catheter
insertion device.
BRIEF DESCRIPTION OF THE DRAWINGS
[0023] FIG. 1 illustrates a perspective view of an implementation of a
catheter
insertion device including a catheter group and an insertion group.
[0024] FIG. 2A illustrates an exploded view of the separate components of the
catheter group of the catheter insertion device. FIG. 2B illustrates a
partially transparent
perspective view of the assembled catheter group of the catheter insertion
device.
[0025] FIG. 3A illustrates an exploded view of the separate components of the
insertion group of the catheter insertion device. FIG. 3B illustrates a
perspective view of the
assembled insertion group of the catheter insertion device. FIG. 3C
illustrates a perspective
view of an assembled insertion group of the catheter insertion device having
another
implementation of the needle guard.
7
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[0026] FIG. 4 illustrates a side view of a right housing of an assembled
catheter
insertion device.
[0027] FIG. 5 illustrates a cross-sectional view of a handle of an assembled
catheter
insertion device.
[0028] FIG. 6 illustrates a transparent side view of a portion of a slider of
the insertion
group of the catheter insertion device.
[0029] FIG. 7A illustrates the left side of a release of the insertion group
of the
catheter insertion device. FIG. 7B illustrates the right side of the release
of the insertion
group of the catheter insertion device.
[0030] FIG. 8A illustrates a partially transparent perspective view of a
region of the
assembled catheter insertion device. FIG. 8B illustrates a partial cross-
sectional view of the
region of the assembled catheter insertion device along the center
longitudinal plane of the
handle. FIG. 8C illustrates a partial cross-sectional view of the region of
the assembled
catheter insertion device along the center longitudinal plane of the handle
following actuation
of the slider by the practitioner. FIG. 8D illustrates a partial cross-
sectional view of the
region of the assembled catheter insertion device along the center
longitudinal plane of the
handle following actuation of the release by the practitioner.
[0031] FIG. 9A illustrates a perspective view of a needle safety clip mounted
to a
catheter hub of the catheter group of the catheter insertion device. FIG. 9B
illustrates a rear
view of the needle safety clip. FIG. 9C illustrates a front view of the needle
safety clip. FIG.
9D illustrates a perspective view of the needle safety clip released from the
catheter hub of
the catheter group of the catheter insertion device. FIG. 9E illustrates a
perspective view of a
sharp needle tip of the needle. FIG. 9F illustrates the sharp needle tip being
withdrawn from
the needle safety clip.
8
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[0032] FIG. 10A illustrates the insertion group being pulled proximally such
that the
catheter group is distal of the handle. FIG. 10B illustrates the insertion
group being pulled
proximally to the point where the sharp needle tip of the needle is between
two distal walls of
the needle safety clip. FIG. 10C illustrates the insertion group being pulled
proximally to the
point where the sharp needle tip of the needle is proximal of both the two
distal walls of the
needle safety clip and is tilted relative to the needle safety clip.
[0033] FIG. 11A illustrates a perspective view of a rigid hub of the catheter
group of
the catheter insertion device. FIG. 11B illustrates a cross-sectional view of
the rigid hub of
the catheter group of the catheter insertion device.
[0034] FIG. 12A illustrates a perspective view of a first implementation of a
valve.
FIG. 12B illustrates a partial cross-sectional view of the first
implementation of the valve
within the catheter hub of the catheter group.
[0035] FIG. 13A illustrates a perspective view of a second implementation of a
valve
having two parts. FIG. I3B illustrates a proximal part of the two-part valve.
FIG. 13C
illustrates a distal part of the two-part valve. FIG. 13D illustrates a
partial cross-sectional
view of the second implementation of the valve within the catheter hub of the
catheter group.
[0036] FIG. 14 illustrates a partial cross-sectional view of a third
implementation of a
valve within the catheter hub of the catheter group.
[0037] FIG. 15 illustrates a partial cross-sectional view of a fourth
implementation of
a valve within the catheter hub of the catheter group.
[0038] FIG. 16 illustrates a perspective view of a distal region of the needle
showing a
plurality of echogenic features.
[0039] FIGs. 17-25 each illustrate an alternative implementation of catheter
insertion
device.
9
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[0040] Implementations of the catheter insertion device are described with
reference
to the drawings, in which like reference numerals refer to like parts
throughout.
DETAILED DESCRIPTION
[0041] Referring to FIG. 1, a perspective view of an implementation of a
catheter
insertion device 100 including a catheter group 102 and an insertion group 104
is illustrated.
The insertion group 104 can be separated from the catheter group 102 following
partial
insertion of a catheter 106 in the vasculature of a patient. The catheter
group 102 also
includes an extension line assembly 108 in fluid communication with the
catheter 106. The
extension line assembly 108 can be connected to a fluid source or an
aspiration device. The
insertion group 104 includes a handle 110 that is initially connected to the
catheter group 102
and that facilitates the insertion of the catheter 106 in the vasculature of
the patient.
[0042] Referring to FIG. 2A, an exploded view of the separate components of
the
catheter group 102 of the catheter insertion device 100 is illustrated.
Referring to FIG. 2B, a
partially transparent perspective view of the assembled catheter group 102 of
the catheter
insertion device 100 is illustrated. At its proximal region, the catheter
group 102 includes an
extension line assembly 108 that includes an elongated extension line 112, an
extension line
clamp 114, and an extension line hub 116. The elongated extension line 112
defines an
elongated lumen that is in fluid communication with the lumen defined by the
catheter 106
through the lumen defined by a rigid hub 120. The extension line clamp 114 is
received
around the elongated extension line 112 and can be slid in a direction
perpendicular to the
longitudinal axis of the elongated extension line 112 to pinch the elongated
extension line
112 closed. When the extension line clamp 114 pinches the elongated extension
line 112,
fluid is prevented from flowing beyond the extension line clamp 114 either
distally towards
the catheter 106 or proximally towards the extension line hub 116. The
extension line hub
CA 3033276 2019-02-07

116 defines a lumen that is in fluid communication with the lumen defined by
the elongated
extension line 112.
[0043] In some implementations, the lumen defined by the extension line hub
116 can
be tapered from its proximal end towards its distal end, while in other
implementations, the
lumen defined by the extension line hub 116 can have a uniform diameter. The
proximal end
of the extension line hub 116 includes a connector, such as a threaded luer
lock illustrated in
FIG. 2, for connection to a fluid source or an aspiration device. The fluid
source can be, for
example, a syringe or an intravenous bag.
[0044] At its distal end, the catheter group 102 includes the elongated
catheter 106
that is connected to a juncture hub 118. In particular, the proximal end of
the elongated
catheter 106 connects to the distal end of the juncture hub 118. The rigid hub
120 is partially
received within the proximal end of the juncture hub 118. The rigid hub 120
receives a seal,
such as a valve 122, within an internal cavity defined by the rigid hub 120.
The proximal end
of the rigid hub 120 is sealed by a rigid hub cap 124. The proximal end of the
rigid hub cap
124 has an opening that allows the needle cannula 130 and the guidewire 132 to
pass through
the rigid hub cap 124 to the valve 122. The elongated catheter 106 defines an
elongated
lumen that is at least partially received within the vasculature of the
patient. The juncture hub
118 defines a tapered cavity that is in fluid communication with the lumen
defined by the
elongated catheter 106 and the lumen defined by the rigid hub 120. The rigid
hub 120 also
includes a side port 121 for receiving the elongated extension line 112 of the
extension line
assembly 108. The lumen defined by the side port 121 is in fluid communication
with the
lumen defined by the elongated extension line 112.
[0045] The valve 122 can be a one-piece valve or a multiple piece valve, as
described
in greater detail below. When the catheter group 102 is assembled, the valve
122 is enclosed
by the rigid hub 120 and the rigid hub cap 124. In some implementations, the
catheter group
11
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102 may not include the extension line assembly 108 and the fluid source or
aspiration device
can be connected to a proximal end of the rigid hub 120.
[0046] Referring to FIG. 3A, an exploded view of the separate components of
the
insertion group 104 of the catheter insertion device 100 is illustrated.
Referring to FIG. 3B, a
perspective view of the assembled insertion group 104 of the catheter
insertion device 100 is
illustrated. The insertion group 104 includes the handle 110 that is made up
of a right
housing 126 and a left housing 128 that are connected together. Top arm 127
and bottom arm
129 are formed in the distal region of the handle 110. A needle cannula 130 is
held within the
handle 110 and a guidewire, which slides through the lumen defined by the
needle cannula
130, is also held within the handle 110. The needle cannula 130 can be
anchored within the
handle 110 by an interference fit within an inner channel defined by the
handle 110, by an
adhesive, by a threaded connection, or the like. In some embodiments, the
needle cannula
130 can be, for example, a 24 gauge needle.
[0047] A needle safety clip 134 is placed around the outer surface of the
needle
cannula 130 to cover the sharp needle tip 131 following separation of the
insertion group 104
from the catheter group 102. A needle guard 136 covers the portion of the
needle cannula
130 extending from the handle 110 before initial use of the catheter insertion
device 100. A
first actuator, such as a slider 138, is connected to the top of the handle
110 and to the
guidewire 132 and slides the guidewire 132 relative to the handle 110 in both
proximal and
distal directions. In some embodiments, the guidewire 132 can be a spring wire
guide, such
as a coiled or a coil-less spring wire guide. The length of the guidewire 132
is selected such
that, before the slider 138 is actuated, the distal end of the guidewire does
not extend beyond
the sharp needle tip 131 of the needle cannula 130.
[0048] In some embodiments, the guidewire 132 can have an outer diameter that
is
substantially uniform and less than or equal to 0.010 inches (0.0254
centimeters). Preferably,
12
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the guidewire 132 has an outer diameter that is less than or equal to 0.010
inches when the
needle cannula 130 is a 24 GA needle and the elongated catheter 106 is a 22 GA
catheter, so
that the guidewire 132 can fit within the lumen defined by the 22 GA catheter.
In other
embodiments, the guidewire 132 can have a varying diameter that narrows
distally, such that
the diameter of the guidewire 132 is the smallest at a distal end of the
guidewire 132. In
some embodiments the guidewire 132 can be made of, for example, a metal, such
as a metal
alloy. For example, the guidewire 132 can be made of an alloy of nickel and
titanium. In
some embodiments, the guidewire 132 can be coated with polysulfones,
polyfluorocarbons,
polyolefins, polyesters, polyurethanes, blends and/or copolymers.
[0049] A second actuator, such as a release 140, is also connected to the
handle 110
and to the catheter group 102 and slides the catheter group 102 relative to
the handle 110 in a
distal direction. The release 140 includes a proximal arm 174 having an
enlarged proximal
end 141. A needle support 142 is attached to a proximal region of the handle
110 and swings
upward and downward relative to the handle 110 rotationally coupled to the top
arm 127.
The needle support 142 includes two parallel walls 143 separated by a distance
slightly
greater than the outer diameter of the elongated catheter 106 in which the
needle cannula 130
passes to stabilize lateral movement of the needle cannula 130 during
insertion of the needle
in the vasculature of the patient. This stabilization is especially important
for insertion of the
needle relatively deep in the tissue of the patient, such as within an organ
of the patient. The
needle support 142 also includes a top portion 147 that abuts the bottom
surface of the slider
138 before the slider 138 is slid proximally to prevent swinging of the
release 140 while the
catheter insertion device 100 is being inserted in the vasculature of the
patient.
[0050] Referring to FIG. 3C, a perspective view of an assembled insertion
group 104
of the catheter insertion device 100 having another implementation of the
needle guard 137 is
illustrated. The needle guard 137 includes an open channel 260 defined by two
parallel side
13
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walls 262. A bottom longitudinal feature 264 and a top longitudinal feature
266 between the
parallel side walls 262 secure around the needle cannula 130. As such, the
bottom
longitudinal feature 264 and the top longitudinal feature 266 are spaced apart
by a distance
slightly greater than the outer diameter of the needle cannula 130. The needle
guard 137 also
includes a tab 268 at the proximal end of the needle guard 137 to allow the
practitioner to
initially lift the needle guard 137 out of contact with the slider 138 and
then push the needle
guard 137 distally until the proximal ends of the bottom longitudinal feature
264 and the top
longitudinal feature 266 are distal of the sharp needle tip 131. At this
point, the needle guard
137 disengages from the insertion group 104 and can be removed to expose the
sharp needle
tip 131.
[0051] Referring to FIG. 4, a side view of the right housing 126 including the
slider
138 and the guidewire 132 is illustrated. The handle 110 includes a looped
proximal end 144
through which the guidewire 132 passes. In particular, the guidewire 132
passes through the
channel 145 defined by the handle 110. The diameter of the channel 145 is
slightly greater
than the diameter of the guidewire 132 so that the guidewire 132 stably passes
through the
channel 145. The slider 138 can be slid by a finger, such as the index finger
in overhand
operation or the thumb in underhand operation, of a practitioner proximally
and distally
within a chamber 146 defined by the handle 110. The chamber 146 is sized to be
slightly
larger than the slider 138 to stabilize the movement of the slider 138 within
the chamber 146.
[0052] Due to the looping of the guidewire 132 within the looped proximal end
144,
proximal movement of the slider 138 translates into distal movement of the
distal tip of the
guidewire 132 and vice versa. The looping of the guidewire 132, as opposed to
a linear
geometry, also enables one-handed operation of the catheter insertion device
100 while
maintaining continuous grip of the gripping features 148 of the handle 110. In
addition, the
14
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looping of the guidewire 132 reduces the likelihood of piercing the
vasculature of the patient
during advancement of the guidewire 132 due to the force of the practitioner
being indirectly
applied to the guidewire 132.
[00531 Referring to FIG. 5, a cross-section view of the assembled handle 110
with the
guidewire 132 and the slider 138 is illustrated. The handle 110 includes
gripping features 148
that help the practitioner grip the handle 110 of the catheter insertion
device 100. A right-
handed practitioner can, for example, grip the gripping feature 148 on the
left housing 128
using his thumb and grip the gripping feature 148 on the right housing using
his middle finger
or left-handed practitioner can, for example, grip the gripping feature 148 on
the left housing
128 using his middle finger and grip the gripping feature 148 on the right
housing using his
thumb. The handle 110 can be gripped by the practitioner overhand or underhand
using the
same fingers. Although depressed lines are shown as the gripping features 148,
any gripping
feature can be formed on the outer surface of the handle 110. For example,
raised lines can
be formed in place of the depressed lines, a textured surface can be formed, a
plurality of
bumps can be formed, or a different material, such as rubber, can be formed
over the region
of the handle 110 corresponding to the gripping features 148.
[0054] Three openings are defined by the front face 150 of the handle 110. The

bottom opening 152 is sized to receive the rigid hub cap 124 of the catheter
group 102. In
particular, the diameter of the bottom opening 152 is slightly greater than
the diameter of the
rigid hub cap 124. The middle opening 154 is sized to receive the guidewire
132 and the
needle cannula 130, and the top opening 156 is sized to receive the slider 138
and the
proximal arm of the release 140 (not shown). The top opening 156 includes a
wider bottom
region that receives the slider 138 and a narrower top region that receives
the proximal arm of
the release 140. The bottom opening 152 and the middle opening 154 are
separated by a
portion of the handle 110, whereas the middle opening 154 and the top opening
156 are not
CA 3033276 2019-02-07

separated to allow a bottom arm 158 (not shown) of the slider 138 to slide
within middle
opening 154, as explained in greater detail below.
[0055] In particular, referring to FIG. 6, a transparent side view of a
portion of the
slider 138 is illustrated. The slider 138 includes a bottom arm 158 extending
from the bottom
of the slider 138 in a direction perpendicular to the longitudinal axis of the
slider 138. The
bottom arm 158 includes a through hole 160 that receives the proximal end 133
of the
guidewire 132. The through hole 160 has an internal diameter that is slightly
larger than the
outer diameter of the guidewire 132 but slightly smaller than the diameter of
the ball 162
formed at the end of the guidewire 132. The guidewire 132 is therefore secured
within the
through hole 160 by a interference fit. The through hole 160 does not extend
along the
entirety of the length of the bottom arm 158, such that the distal end of the
through hole 160
is closed. Although the ball 162 is secured within the through hole 160 by a
interference fit,
in some implementations, the ball 162 can be secured by an adhesive, by a
threaded
connection, or the like.
[0056] Due to the interference fit between the through hole 160 and the
guidewire
132, as the slider 138 is moved in a longitudinal direction for a given
distance, the guidewire
will also move in the opposite direction for the same distance and vice versa.
The slider 138
includes one or more grips 164 that allow a finger, such as the index finger
in an overhand
operation or the thumb in an underhand operation, of the practitioner to
predictably actuate
the slider 138 in either a distal or proximal direction. In some embodiments,
as shown in
FIG. 6, the grips 164 can be shaped like arrows that point in the proximal
direction. Adjacent
to each grip 164 can be an indicator 166, such as a number, that indicates a
relative extension
of the guidewire 132 distally from the sharp needle tip 131.
[0057] Referring to FIG. 7A, the left side of the release 140 includes a notch
168 that
receives the side port 121. The release 140 is sized to be received from
around the bottom
16
CA 3033276 2019-02-07

arm 129 to the slider 138. The notch 168 is sized to be slightly larger than
the diameter of the
side port 121 to stably secure the side port 121. When the practitioner
actuates the release
140 in a distal direction using, for example, his index finger, the catheter
group 102 is also
actuated in the distal direction by the same distance through the interface
between the notch
168 and the side port 121.
[0058] Referring to FIG. 7B, the right side of the release 140 includes a
continuous
side wall 170. If the practitioner's finger were to push down onto the slider
138 or top arm
127 of the handle 110 while the needle cannula 130 is still in the vasculature
of the patient,
the resulting downward movement of the needle cannula 130 may cause damage to
the
vasculature of the patient. As such, to help prevent the practitioner's finger
from slipping
past the distal end of the release 140, the release 140 includes a distal lip
172 that extends
radially outward from the release 140.
[0059] The release 140 also includes a proximal arm 174 having an enlarged
proximal
end 141 (not shown). The proximal arm 174 slides within the top opening 156 of
the handle
110. The enlarged proximal end of the release 140 is dimensioned to be larger
than the top
opening 156 so that distal movement of the release 140 is limited to the
length of the
proximal arm 174 and so that the release 140 does not separate from the handle
110. The
release 140 can also include a grip 176 that allow a finger, such as the index
finger in an
overhand operation or the thumb in an underhand operation, of the practitioner
to predictably
actuate the release 140 in either a distal or proximal direction.
[0060] Referring to FIG. 8A, a partially transparent perspective view of a
region of
the assembled catheter insertion device 100 is illustrated. The bottom arms
129 of the right
housing 126 and the left housing 128 abut against one another to support the
weight of the
juncture hub 118. The top arms 127 of the right housing 126 and the left
housing 128 are
spaced apart by a distance slightly greater than the width of the needle
support 142 to allow
17
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the needle support 142 to swing upwards during removal of the catheter group
102. The
needle support 142 includes two parallel walls 143 that are perpendicular to
the plane of the
top surface of the bottom arms 129. As explained above, the parallel walls 143
are spaced
apart by a distance slightly greater than the outer diameter of the elongated
catheter 106 to
stabilize the needle cannula 130 during insertion into the vasculature of the
patient. Both top
arms 127 also include a groove 178 that received a corresponding tongue of the
needle guard
136. The tongue and groove connection stably secures the needle guard 136 to
the handle
110 before use of the catheter insertion device 100.
[0061] Before the practitioner slides the slider 138 proximally, the distal
end 139 of
the slider 138 extends beyond the distal end of the top arm 127 and, as such,
extends distally
beyond the needle support 142. As shown in FIG. 8B, which illustrates a
partial cross-
sectional view of the region of the assembled catheter insertion device 100
along the center
longitudinal plane of the handle 110, the bottom surface of the slider 138
abuts against the top
portion 147 before the slider 138 is slid proximally to prevent swinging of
the release 140
while the catheter insertion device 100 is being inserted in the vasculature
of the patient.
[0062] FIG. 8C illustrates a partial cross-sectional view of the region of the
assembled
catheter insertion device 100 along the center longitudinal plane of the
handle 110 following
actuation of the slider 138 by the practitioner. As shown in FIG. 8C, the
distal end 139 of the
slider 138 is proximal of the needle support 142 so that the top portion 147
no longer abuts
the bottom surface of the slider 138 and is free to swing upwards as the
catheter group 102 is
separated from the insertion group 104.
[0063] FIG. 8D illustrates a partial cross-sectional view of the region of the
assembled
catheter insertion device 100 along the center longitudinal plane of the
handle 110 following
actuation of the release 140 by the practitioner. As shown in FIG. 8D, the
release 140 pushes
the rigid hub 120 distally so that the distal end of the juncture hub 118
extends distally
18
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beyond the needle support 142. As the juncture hub 118 initially abuts and
distally moves
past the needle support 142, the needle support 142 swings upward to provide
clearance for
full deployment of the catheter group 102.
[0064] Referring to FIG. 9A, a perspective view of the needle safety clip 134
mounted
to the rigid hub 120 is illustrated. Referring to FIG. 9B, a rear view of the
needle safety clip
134 is illustrated. Referring to FIG. 9C, a front view of the needle safety
clip 134 is
illustrated. The needle safety clip 134 includes a proximal wall 180 that
includes a round
aperture 182 having a diameter slightly greater than the outer diameter of the
needle cannula
130. In some implementations, the round aperture 182 can have a sharp inner
surface to grip
the outer surface of the needle cannula 130 when the needle cannula 130 is at
an angle with
respect to the central axis of the round aperture 182. In other words, the
sharp inner surface
of the round aperture 182 digs into the outer surface of the needle cannula
130 when the
needle cannula 130 is tilted with respect to the needle safety clip 134, as
shown in FIG. 9D, to
prevent movement of the needle cannula 130 with respect to the needle safety
clip 134.
[0065] Referring back to FIG. 9A, a top wall 184 extends distally of the
proximal wall
180 and defines a top opening 186. The top opening 186 allows the spring arm
188 to extend
partially above the top wall 184 in its compressed state, as shown in FIG. 9A.
The spring arm
188 is illustrated to be C-shaped. However, the spring arm 188 can be designed
to have other
shapes that are resilient and can be shaped to be, for example, stepped,
blocked, jagged, or
amorphous. The top distal portion of the spring arm 188 is connected to the
distal bottom
surface of the top wall 184 to secure the spring arm 188 to the rest of the
needle safety clip
134. The spring arm 188 can be made of any flexible material, such as, for
example, plastic,
stainless steel, aluminum or titanium. The spring arm 188 can be made of the
same material
as the rest of the needle safety clip 134 or made of a different material
having the desired
characteristics.
19
CA 3033276 2019-02-07

[0066] A first distal wall 190 extends downward from the distal end of the top
wall
184 and defines a first distal channel. A second distal wall 194 curves upward
from the first
distal wall 190 and defines a second distal channel. A narrow tab 198 extends
distally from
the distal end of the second distal wall 194 and a broad tab 200 extends
distally from the
narrow tab 198. The narrow tab 198 is received within a narrow recess 202 at
the top of the
rigid hub cap 124 and the broad tab 200 is received within a broad recess 204
at the top of the
rigid hub cap 124 to mount the needle safety clip 134 to the rigid hub cap
124. When the
needle safety clip 134 is mounted to the rigid hub cap 124, the narrow tab 198
prevents lateral
movement of the needle safety clip 134 while broad tab 200 prevents
longitudinal movement
of the needle safety clip 134.
[0067] Referring back to FIG. 9C, the first distal wall 190 defines a channel
having a
round top region 191 and a rectangular bottom region 192. The diameter of the
round top
region 191 is slightly larger than the outer diameter of the needle cannula
130 to allow the
needle cannula 130 to slide through the round top region 191 with low friction
and to prevent
lateral movement of the needle cannula 130. The rectangular bottom region 192
has a width
that is less than the outer diameter of the needle cannula 130 to block the
needle cannula 130
from being able to extend distally past the second distal wall 194, as
explained in greater
detail below. The second distal wall 194 also includes a round top region 195
that has a
diameter that is greater than the outer diameter of the needle cannula 130 and
a rectangular
bottom region 196. The width of the rectangular bottom region 196 can be equal
to the
diameter of the round top region 195 to allow the needle cannula 130 to move
downward
relative to the needle safety clip 134 under force of the spring arm 188.
[0068] Referring to FIG. 9D, a perspective view of the needle safety clip 134
released
from the rigid hub 120 is illustrated. After the needle cannula 130 is
withdrawn from the
rigid hub 120, it passes proximally through the round top region 195 of the
second distal wall
CA 3033276 2019-02-07

194 and then through the round top region 191 of the first distal wall 190.
Once the round top
region 191 does not stabilize the needle cannula 130, the needle cannula 130
is free to tilt
relative to the needle safety clip 134. The spring arm 188 then decompresses,
as shown in
FIG. 9D, to push the needle safety clip 134 upward. Because the needle cannula
130 is still
within the round aperture 182, it is gripped by the sharp inner edges of the
round aperture
182, which prevents longitudinal movement of the needle cannula 130 with
respect to the
needle safety clip 134. As such, the first distal wall 190 and the second
distal wall 194 cover
the sharp needle tip 131 and protect the practitioner from potential needle
pricks.
[0069] Referring to FIG. 9E, a perspective view of the sharp needle tip 131 of
the
needle cannula 130 is illustrated. As shown in FIG. 9E, the sharp needle tip
131 can have a
lancet tip or, in other implementations, the sharp needle tip 131 can be
formed by back
grinding. The sharp needle tip 131 tapers in the distal direction such that
the width W,, of the
sharp needle tip 131 at a plane along the sharp needle tip 131 is equal to the
width of the
rectangular bottom region 192. As such, the needle cannula 130 cannot extend
distally past
the first distal wall 190 beyond that plane where the sharp needle tip 131 has
the width W,,
when the needle safety clip 134 is released from the rigid hub 120 because the
needle cannula
130 is wider than the rectangular bottom region 192 proximal of that plane.
However, the
length Lr, can still extend distally beyond the first distal wall 190 because
the needle cannula
130 is thinner than the rectangular bottom region 192 distal of that plane.
Therefore, as
shown in FIG. 9F, to prevent exposure of the sharp needle tip 131 beyond the
second distal
wall 194, the needle safety clip 134 is designed so that the distance De
between the first distal
wall 190 and the second distal wall 194 in the axis aligned with the
longitudinal axis of the
needle cannula 130 is greater than the length L.
[0070] Referring to FIGs. 10A-C, partially transparent side views of the
catheter
insertion device 100 during separation of the catheter group 102 are
illustrated. As explained
21
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above in connection with FIG. 8D, the release 140 is initially slid distally
to allow the needle
support 142 to swing upwards. The practitioner then uses the hand that is not
grasping the
handle 110 to stabilize the catheter group 102. For example, the practitioner
can use his non-
dominant hand to grasp the juncture hub 118 and/or the rigid hub 120 to
stabilize the rigid
hub 120 at a constant position within the vasculature of the patient. The
practitioner can then
pull the insertion group 104 proximally to remove the needle cannula 130 from
the catheter
group 102.
[0071] As shown in FIG. 10A, the insertion group 104 is pulled proximally such
that
the catheter group 102 is distal of the distal end of the handle 110. At this
point, the needle
safety clip 134 is still mounted to the rigid hub cap 124, as explained above.
As shown in
FIG. 1013, the insertion group 104 is pulled proximally to the point where the
sharp needle tip
131 of the needle cannula 130 is proximal of the second distal wall 194, but
still distal of the
first distal wall 190. As such, the plane where the sharp needle tip 131 has
the width W. is
still distal of the first distal wall 190 and the needle cannula 130 is
stabilized within the round
top region 191. As shown in FIG. 10C, the sharp needle tip 131 is proximal of
the first distal
wall 190 and, therefore, free to tilt relative to the needle safety clip 134.
The spring arm 188
then decompresses to tilt the needle cannula 130 downward, so that the first
distal wall 190
and/or the second distal wall 194 cover the sharp needle tip 131.
[0072] Referring to FIG. 11A, a perspective view of the rigid hub 120 is
illustrated.
The rigid hub 120 can include two or more compression ribs 206 protruding
radially inward
along an inner circumference of the proximal end of the rigid hub 120 to allow
for oversizing
of the valve 122. The compression ribs 206 grip the valve 122 within the rigid
hub 120. The
radial interference caused by the compression ribs 206 on the valve 122 acts
to seal the
puncture hole created by the needle cannula 130 with the valve 122 following
separation of
the catheter group 102 from the insertion group 104. The areas between the
compression ribs
22
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206 provide a region for the material of the valve 122 to displace when the
valve 122 is
compressed.
[0073] Referring to FIG. 11B, a cross-sectional view of the rigid hub 120
taken along
the plane defined by the diameter of the rigid hub 120 and the longitudinal
axis of the side
port 121 is illustrated. The smooth region 208 just distal of the compression
ribs 206 has a
diameter that is smaller than the diameter of the valve 122 to radially seal
the valve 122
within the rigid hub 120. The annular flange 210 abuts against the flat distal
face 214 of the
valve 122 to prevent distal movement of the valve 122 when the needle eannula
130 applies
distal pressure to the valve 122.
[0074] Referring to FIG. 12A, a perspective view of a first implementation of
the
valve 211 is illustrated. The valve 211 includes a flat proximal face 212 and
a flat distal face
214. The valve 211 has a substantially uniform outer diameter in the regions
that are received
within the rigid hub 120 to allow for a compression fit within the rigid hub
cap 124. The
proximal region of the valve 211 has a wedged surface 216 that enlarges
distally. The valve
221 is solid and made of a resilient material, such as, for example, silicon,
rubber,
polyisoprene, or the like.
[0075] Referring to FIG. 12B, a partial cross-sectional view of the assembled
rigid
hub 120, valve 122, and rigid hub cap 124 taken along the plane defined by the
diameter of
the rigid hub 120 and the longitudinal axis of the side port 121 is
illustrated. The wedged
surface 216 of the valve 211 is compressed within the rigid hub cap 124 to
force the valve
material radially inward in response to pressure applied to the flat distal
face 214. As shown
in FIG. 12B, the flat distal face 214 is flush with the distal end of the
rigid hub cap 124 to
allow for complete evacuation of the inner volume of the rigid hub 120 when
flushing the
catheter insertion device 100.
23
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[0076] Referring to FIG. 13A, a perspective view of a second implementation of
the
valve 218 is illustrated. The valve 218 is a two-part valve that includes a
proximal part 220
and a distal part 222. Referring to FIG. 13B, the proximal part 220 has a flat
proximal face
224 and a proximal region 228 having a reduced diameter. The proximal part 220
defines an
inner cavity 230 that extends along a majority of the longitudinal axis of the
proximal part
220. Relative to the valve 211, the inner cavity 230 reduces the surface area
of the valve 218
that the needle cannula 130 must pass through, thereby reducing the force
required to insert
the needle cannula 130.
[0077] Referring to FIG. 13C, the distal part 222 is solid and includes a
proximal
region 232 of reduced diameter. The diameter of the proximal region 232 is
slightly smaller
than the diameter of the inner cavity at the distal end of the proximal part
220 to prevent
lateral movement of the distal part 222 relative to the proximal part 220 when
the valve 218 is
assembled within the rigid hub 120 and the rigid hub cap 124. The distal part
222 also has a
tapered distal region with a diameter that reduces distally. The valve 218 can
be made of a
resilient material, such as, for example, silicon, rubber, polyisoprene, or
the like.
[0078] Referring to FIG. 13D, a partial cross-sectional view of the assembled
rigid
hub 120, two-part valve 218, and rigid hub cap 124 taken along the plane
defined by the
diameter of the rigid hub 120 and the longitudinal axis of the side port 121
is illustrated. The
proximal region 228 having the reduced diameter is compressed within the rigid
hub cap 124
to force the valve material radially inward in response to pressure applied to
the flat distal
face 226. The flat distal face 226 is flush with the distal end of the rigid
hub cap 124 to allow
for complete evacuation of the inner volume of the rigid hub 120 when flushing
the catheter
insertion device 100.
[0079] Referring to FIG. 14, a cross-sectional view of the assembled rigid hub
120, a
third implementation of a two-part valve 236, and the rigid hub cap 124 taken
along the plane
24
CA 3033276 2019-02-07

defined by the diameter of the rigid hub 120 and the longitudinal axis of the
side port 121 is
illustrated. The valve 236 is a two-part valve that includes a proximal part
238 and a distal
part 240. The proximal part 238 and the distal part 240 each define mirrored
inner cavities
that together define the inner cavity 242. As is the case with regard to the
valve 218, the
inner cavity 242 reduces the surface area of the valve 236 that the needle
cannula 130 must
pass through, thereby reducing the force required to insert the needle cannula
130. Based on
the shape of the valve 236, the inner cavity of the proximal part 238 improves
sealing when a
vacuum is applied to the distal face of the distal part 240 following removal
of the needle
cannula 130. The inner cavity of the distal part 240 improves sealing when a
high pressure is
applied to the distal face of the distal part 240 following removal of the
needle cannula 130.
The valve 236 can be made of a resilient material, such as, for example,
silicon, rubber,
polyisoprene, or the like.
[0080] Referring to FIG. 15, a partial cross-sectional view of the assembled
rigid hub
120, a fourth implementation of a two-part valve 244, and the rigid hub cap
124 taken along
the plane defined by the diameter of the rigid hub 120 and the longitudinal
axis of the side
port 121 is illustrated. The valve 244 is a two-part valve that includes a
proximal part 246
and a distal part 248. The proximal part 246 defines a proximal inner cavity
250 and the
distal part 240 defines a relatively smaller distal inner cavity 252. Due to
the compression
provided by the rigid hub cap 124 on the proximal part 246 and the rigid hub
120 on the distal
part 248, the valve 244 is sealed closed following removal of the needle
cannula 130 from the
valve 244.
[0081] Moreover, because of the distal inner cavity 252, the distal part 248
is forced
radially inward to close the channel formed by the needle cannula 130 under
pressure applied
to the distal face 254 of the distal part 248. The pressure applied to the
distal face 254 pushes
CA 3033276 2019-02-07

the proximal part 246 proximally, which causes the wedged surface 256 of the
valve 244 to
compress within the rigid hub cap 124 and for the valve material radially
inward.
[0082] In contrast, when a vacuum is applied to the distal face 254 of the
distal part
248, the channel formed by the needle cannula 130 in the distal part 248 is
forced open. The
inner cavity of the proximal part 238, however, improves sealing when the
vacuum is applied
to the distal face 254 of the distal part 248 following removal of the needle
cannula 130. In
particular, the proximal part 246 is pulled distally which also causes the
proximal part 246 to
compress radially inward, thereby preventing air from entering the proximal
inner cavity 250
from the outside environment. The valve 244 can be made of a resilient
material, such as, for
example, silicon, rubber, polyisoprene, or the like.
[0083] Referring to FIG. 16, a perspective view of a distal region of the
needle
cannula 130 is illustrated. The distal region of the needle cannula 130
includes one or more
and, preferably, eight echogenic features. The echogenic features can be, for
example,
through holes 258 drilled within opposite sides of the needle cannula 130.
Although the
sharp needle tip 131 is echogenic when observed under ultrasound, the through
holes 258
improve the echogenicity of the needle cannula 130. In particular, the through
holes 258 are
visible through the wall thickness of the enlogated catheter 106 under
ultrasound. In addition,
through holes 258 allow for blood flow from within the lumen of the needle
cannula 130 to
the outer surface of the needle cannula 130. The blood then flows to the inner
surface of the
catheter 106 to allow for visual observation of the blood.
[0084] The through holes 258 are angled relative to one another. For example,
the
through holes 258 are drilled 90 degrees apart from one another, as shown in
FIG. 16. The
different angles of the through holes 258 and the number of through holes 258
results in at
least two echogenic features being visible under ultrasound at all times ¨ one
echogenic
feature being the sharp needle tip 131 and the other being at least one of the
through holes
26
CA 3033276 2019-02-07

258. The two visible echogenic features enable the practitioner to know the
angle of insertion
of the needle cannula 130.
[0085] The many features and advantages of the catheter insertion device 100
are
apparent from the detailed specification, and thus, the claims cover all such
features and
advantages within the scope of this application. Further, numerous
modifications and
variations are possible. For example, referring to FIGs. 17-25 various
alternative
implementations of catheter insertion devices are illustrated. In particular,
the catheter
insertion device 200 illustrated in FIG. 17 also includes a housing 202, a
slider 204 that can
be slid proximally to advance a guidewire distally and that can be slid
distally to advance the
guidewire proximally, and a release 206 to advance the catheter hub 208.
Relative to the
release 140 of the catheter insertion device 100, the release 206 is actuated
below the slider
204.
[0086] Referring to FIG. 18, the catheter insertion device 300 includes a
housing 302,
a wheeled actuator 304 that can be rotated counter clockwise to advance a
guidewire distally
and that can be rotated counter clockwise to advance the guidewire proximally,
and a release
306 to advance the catheter hub 308. The wheeled actuator 304 limits the
longitudinal
movement of a finger of the practitioner to move the guidewire. In some
implementations,
the wheeled actuator 304 can be geared to further limit the movement of the
practitioner to
move the guidewire.
[0087] Referring to FIG. 19, the catheter insertion device 400 includes a
housing 402,
a linkage actuator 404 having links 405 that can be separately moved
proximally to advance a
guidewire distally and that can be moved distally to advance the guidewire
proximally, and a
release 406 to advance the catheter hub 408. The linkage actuator 404 enables
the
practitioner to control the length of advancement of the guidewire depending
on the link 405
that is actuated.
27
CA 3033276 2019-02-07

[0088] Referring to FIG. 20, the catheter insertion device 500 includes a
housing 502
having grooves to receive the fingers of a practitioner, a piston 504 that is
actuated to advance
a guidewire distally, and a release 506 to disconnect the catheter hub 508.
The piston 504 can
be actuated by the thumb of the practitioner in a stepped manner.
[0089] Referring to FIG. 21, the catheter insertion device 600 includes a
housing 602,
a single flag actuator 604 that is actuated to advance a guidewire distally or
proximally, and a
release 606 to disconnect the catheter hub 608. The release 606 is connected
to the catheter
hub 608 by a threaded connected and can be rotated relative to the catheter
hub 608 to
disconnect from the catheter hub 608. The single flag actuator 604 can be
actuated by the
thumb of the practitioner.
[0090] Referring to FIG. 22, the catheter insertion device 700 includes a
housing 702,
a plunger 704 that is actuated to advance a guidewire distally or proximally,
and a release 706
to disconnect the catheter hub 708. The release 706 is connected to the
catheter hub 708
through interference in the internal geometry of the catheter hub 708 and
disconnects from the
catheter hub 708 upon safety activation. The plunger 704 can be actuated by
the thumb of the
practitioner.
[00911 Referring to FIG. 23, the catheter insertion device 800 includes a
housing 802,
a single flag indicator 804 that is attached to the proximal end of a guide
wire and shows the
position of the guidewire distally or proximally to the tip of the needle, a
partially exposed
gearing mechanism 805 through which the guidewire passes, and a release 806 to
disconnect
the catheter hub 808. The gearing mechanism can be actuated by the finger of
the practitioner
to move the guidewire. Referring to FIG. 24, the catheter insertion device 900
includes a
housing 902, a drum 904 that is directly actuated to advance a guidewire
distally or
proximally, and a release 906 to disconnect the catheter hub 908. The drum 904
can, for
28
CA 3033276 2019-02-07

example, be rotated counter clockwise to advance a guidewire distally and that
can be rotated
counter clockwise to advance the guidewire proximally.
[0092] Referring to FIG. 25, the catheter insertion device 1000 includes a
housing
1002, a slider 1004 that can be slid proximally to advance a guidewire
distally and that can be
slid distally to advance the guidewire proximally, a gearing mechanism or
linkage
configuration 1005 which can control the length of movement of the slider
relative to the
length of advancement of the guidewire, and a release 1006 to advance the
catheter hub 1008.
[0093] As such, it is not desired to limit the catheter insertion device 100
to the exact
construction and operation described and illustrated.
29
CA 3033276 2019-02-07

Representative Drawing
A single figure which represents the drawing illustrating the invention.
Administrative Status

For a clearer understanding of the status of the application/patent presented on this page, the site Disclaimer , as well as the definitions for Patent , Administrative Status , Maintenance Fee  and Payment History  should be consulted.

Administrative Status

Title Date
Forecasted Issue Date 2021-04-20
(22) Filed 2014-06-17
(41) Open to Public Inspection 2015-02-19
Examination Requested 2019-02-07
(45) Issued 2021-04-20

Abandonment History

There is no abandonment history.

Maintenance Fee

Last Payment of $347.00 was received on 2024-06-07


 Upcoming maintenance fee amounts

Description Date Amount
Next Payment if standard fee 2025-06-17 $347.00 if received in 2024
$362.27 if received in 2025
Next Payment if small entity fee 2025-06-17 $125.00

Note : If the full payment has not been received on or before the date indicated, a further fee may be required which may be one of the following

  • the reinstatement fee;
  • the late payment fee; or
  • additional fee to reverse deemed expiry.

Patent fees are adjusted on the 1st of January every year. The amounts above are the current amounts if received by December 31 of the current year.
Please refer to the CIPO Patent Fees web page to see all current fee amounts.

Payment History

Fee Type Anniversary Year Due Date Amount Paid Paid Date
Request for Examination $800.00 2019-02-07
Application Fee $400.00 2019-02-07
Maintenance Fee - Application - New Act 2 2016-06-17 $100.00 2019-02-07
Maintenance Fee - Application - New Act 3 2017-06-19 $100.00 2019-02-07
Maintenance Fee - Application - New Act 4 2018-06-18 $100.00 2019-02-07
Maintenance Fee - Application - New Act 5 2019-06-17 $200.00 2019-02-07
Maintenance Fee - Application - New Act 6 2020-06-17 $200.00 2020-06-12
Final Fee 2021-03-08 $306.00 2021-02-26
Maintenance Fee - Patent - New Act 7 2021-06-17 $204.00 2021-06-11
Maintenance Fee - Patent - New Act 8 2022-06-17 $203.59 2022-06-10
Maintenance Fee - Patent - New Act 9 2023-06-19 $210.51 2023-06-09
Maintenance Fee - Patent - New Act 10 2024-06-17 $347.00 2024-06-07
Owners on Record

Note: Records showing the ownership history in alphabetical order.

Current Owners on Record
TELEFLEX MEDICAL INCORPORATED
Past Owners on Record
None
Past Owners that do not appear in the "Owners on Record" listing will appear in other documentation within the application.
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Document
Description 
Date
(yyyy-mm-dd) 
Number of pages   Size of Image (KB) 
Examiner Requisition 2020-03-13 4 154
Electronic Grant Certificate 2021-04-20 1 2,527
Amendment 2020-07-13 48 1,042
Description 2020-07-13 30 1,218
Claims 2020-07-13 6 194
Drawings 2020-07-13 33 559
Final Fee 2021-02-26 4 100
Representative Drawing 2021-03-22 1 9
Cover Page 2021-03-22 1 42
Abstract 2019-02-07 1 17
Description 2019-02-07 29 1,165
Claims 2019-02-07 7 175
Drawings 2019-02-07 33 2,978
Divisional - Filing Certificate 2019-02-25 1 147
Representative Drawing 2019-05-03 1 51
Cover Page 2019-05-03 2 88